Ref No: DT17908
County Wexford, Republic of Ireland
Quality Engineer - Product Transfer: County Wexford.
This position is being offered as an initial 18 months' contract.
Our client seeks an experienced Quality Engineer with New Product Introduction experience. In this role you will ensure that new products and the processes for manufacturing them meet all local, corporate and divisional requirements with respect to safety and efficacy.
You will support process transfer of medical devices, new products and delivery systems from manufacturing or R&D to the Wexford manufacturing site. This role will represent quality interests and concerns on project teams, assuring that new products and the processes meet all local, divisional and corporate requirements with respect to safety and efficacy. You will be responsible for the execution of the technical tasks of the transfer following an established transfer process. This will involve the different phases of a project including risk management, test method development and validation, qualification and launch of the product. The role will work closely with the different functions on site and between sites.
Other responsibilities may include:
Leads the Quality engineering activities for transfer projects, supporting and participating in NPI teams.
Develops process risk management documentation with cross-functional support.
Develops or assist in development of inspection and test methods per product specifications.
Performs test method validations as required.
Identifies quality systems engineering improvement opportunities and executes through the change management system.
Ensures regulatory / statutory / legislative compliance for all project work.
Interested applicants should have:
Bachelor of Mechanical, Biomedical, Chemical or other related engineering discipline or a Technical/Science qualification (level 8).
At least 2 years' industrial experience in quality engineering or similar, preferably in medical device or other regulated FDA/QSR and ISO environment.
Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and EU MDR
Experience in Risk Management process – PFMEA
Knowledge of Gauge R&R and Test Method Validation for Physical & Mechanical Test Methods
Excellent attention to detail and adaptability
Experience in process validation (IQ, OQ and PQ) is a plus.
Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines.
Problem solving techniques with excellent organisational skills.
Excellent oral and written communication skills.
Ability to analyse data, interpret results, and write reports. Proficient in statistic software is a plus.